BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3141215 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14030
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS NOT CONFIRMED. EVALUATION OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PARTICULATE MATTER. A VISUAL INSPECTION, LEAK TESTING, CLEAR PASSAGE TEST AND A CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES RELATED TO THE REPORTED CONDITION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP PERITONEAL DIALYSIS TRANSFER SET WAS FOUND TO HAVE A HAIR-LIKE SUBSTANCE INSIDE THE TRANSFER SET DURING UNPACKING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243356 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12A10052

    Patients

    Seq Age Sex Outcome Treatment
    1